Denosumab (Prolia®) is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab has an approximate molecular weight of 147 kD and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Prolia® is a sterile, preservative-free, clear, and colorless to pale yellow solution.
Denosumab is presently indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture; as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer (from Prolia® Prescribing Information dated September 2011, Amgen, Inc.)